CN103432151A - Preparation method for compound synergistic tylosin tartrate - Google Patents
Preparation method for compound synergistic tylosin tartrate Download PDFInfo
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- CN103432151A CN103432151A CN2013103647339A CN201310364733A CN103432151A CN 103432151 A CN103432151 A CN 103432151A CN 2013103647339 A CN2013103647339 A CN 2013103647339A CN 201310364733 A CN201310364733 A CN 201310364733A CN 103432151 A CN103432151 A CN 103432151A
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- tylosin tartrate
- trimethoprim
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- tartrate
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Abstract
The invention aims to provide compound synergistic tylosin tartrate for animal injection and a preparation method of the compound synergistic tylosin tartrate. The compound synergistic tylosin tartrate has a quick and definite curative effect on livestock and poultry respiratory system infection and complications, and is prepared by the following steps: mixing 0.2 part of trimethoprim and 0.2 part of a cosolvent, grinding, and treating the mixture through a 120-mesh or thinner sieve; uniformly mixing the mixture with 1 part of tylosin tartrate, 1 part of kanamycin sulfate and 0.05-0.1 part of pain relief agent according to an equal increment method, wherein the cosolvent is citric acid, succinic acid or a mixture of citric acid and butanedioic acid, and the pain relief agent is procaine hydrochloride, lidocaine hydrochloride or a mixture of procaine hydrochloride and lidocaine hydrochloride. The compound synergistic tylosin tartrate contains the three medicinal compents of tylosin tartrate, kanamycin sulfate and trimethoprim. Through the adoption of the compound synergistic tylosin tartrate, the problem that secondary infection cannot be well controlled when the mycoplasma infection is treated due to narrow antibacterial spectrum of tylosin tartrate is solved; the problem that trimethoprim is difficultly dissolved in water is solved, the tylosin tartrate and the kanamycin sulfate are synergistic; the drug curative effect is remarkable.
Description
The application is that application number is: 201210277080.6, and patent name is: the dividing an application of the patent of invention of " preparation method of injection use compound potentiation tylosin tartrate for animals ", the original bill applying date: on 08 06th, 2012.
Technical field
The present invention relates to injection use compound potentiation tylosin tartrate for animals.
Background technology
From the state of development of current China animal husbandry, current poultry respiratory system infection is occurred frequently, complication is seriously large to poultry harm.On market, also there is no now the medicine of comparatively desirable treating both the principal and secondary aspects of a disease.By investigation domestic, international market is found, market is in the urgent need to a kind of efficacy stability, good effect, stability, complication serious specific medicine occurred frequently to the poultry respiratory system infection high, easy to use.
In prior art, tylosin tartrate belongs to vinegar class animal specific antibacterials in macro ring, mainly most gram-positive bacterias, Gram-negative coccus, anaerobe level legionella, mycoplasma, chlamydia is had to good action.Belong to the quick-acting antibacterial of trophophase.Under high concentration, there is bactericidal action, be one of medicine that the macrolide apoplexy due to endogenous wind is the strongest to the mycoplasma effect, be mainly used in preventing and treating pig, avian mycoplasmas disease, as the mycoplasma pneumonia of chronic respiratory disease of fowl (CRD) and infectiousness hole chamber inflammation and pig.
The antimicrobial spectrum of kanamycin sulfate is similar to streptomycin, but effect is slightly strong.Most of gram negative bacterias are had to powerful antibacterial action as escherichia coli, Bacillus proteus, Salmonella and pasteurella multocida etc., also more responsive to gold-coloured staphylococci and tubercule bacillus.Intramuscular injection is used for the various severe infections due to sensitive organism, as septicemia, urogenital infection, respiratory tract infection, Skin and soft tissue infection etc.
Trimethoprim is the broad-spectrum antiseptic synergist, can the antibacterial action of multiple antibiotics be increased substantially (but potentiation several times to tens times), and can reduce the appearance of drug resistance strain.
Injection means the sterile solution that the confession is injected in vivo, emulsion or the suspension that medicine is made, and for the sterilized powder concentrated solution of wiring solution-forming before use or suspension.The characteristics of injection, is mainly manifested in route of administration and organizes (liver) and directly inject tissue or blood vessel without digestive system and defence, so drug effect is rapid, is applicable to first aid.But also the curative effect of some injection is extended, to adapt to the needs in medical treatment.The dosage of injection is accurate, and reliable effect may suffer the impacts such as Digestive system, food, and make the dosage of taking that curative effect can not occur fully unlike endo-medicine.In addition, can make again some drugs performance positioning action.
Injectable sterile powder claims again the powder pin, and injection after dissolving with sterilized water for injection before use, be a kind of injection type more commonly used.Be applicable to unsettled medicine in water, particularly to wet heat sensitive antibiotic and biological product.
Summary of the invention
The purpose of this invention is to provide a kind of injection use compound potentiation tylosin tartrate for animals and preparation method, it has quick, definite curative effect to poultry respiratory system infection and complication.
For achieving the above object, the technical solution adopted in the present invention is: a kind of injection use compound potentiation tylosin tartrate for animals, it is characterized in that, and by the component of following weight ratio, formed:
In described formula, amounts of components is strict, and except pain relief agents, other component does not almost have the leeway of adjusting.Only can on material choice, do following replacement:
Described cosolvent is citric acid or succinic acid or the two is composite.
Described pain relief agents is procaine hydrochloride or lidocaine hydrochloride or the two is composite.
The preparation method of injection of the present invention:
Take trimethoprim, the cosolvent of recipe quantity, mix by fluid energy mill and pulverize, cross 120 orders or thinner sieve;
With tylosin tartrate, kanamycin sulfate, pain relief agents, by the equivalent method of progressively increasing, mix homogeneously again;
Inspection of semifinished product content, dissolubility, qualified rear packing, obtain.
Further, described pulverizing is to pulverize through fluid energy mill.
Further, described sieving as crossing 120 mesh sieves.
The usage of product of the present invention and consumption: first product of the present invention is dissolved as analog such as water for injection or ethylene glycol, ethanol with solvent for injection, then muscle or subcutaneous injection.In tylosin tartrate: amount once, every 1kg body weight, pig, fowl 5～13mg, once a day.
The injection use compound potentiation tylosin tartrate for animals of the present invention's development, include tylosin tartrate, kanamycin sulfate, three kinds of pharmaceutical compositions of trimethoprim.Three kinds of ingredients composite not only for indication more extensive, and enhancing evident in efficacy.And there is the following effect of having a mind to:
1, develop a kind of injection use compound potentiation tylosin tartrate for animals and preparation method thereof is provided for veterinary clinic;
2, solved due to the tylosin tartrate narrow antimicrobial spectrum, treatment can not fine control secondary infection during mycoplasma infection;
3, solve the problem that trimethoprim is insoluble in water, and paratartaric acid tylosin and kanamycin sulfate potentiation;
4, be injectable sterile powder, preparation stabilization, storage period is long;
5, rapid-action, duration of efficacy is long, and bioavailability is high;
6, use safety, determined curative effect, quality controllable;
7, dosage is accurate, easy to use;
8, irritating property is little, reduce to poultry stress.
The specific embodiment
Embodiment mono-
Tylosin tartrate 1g, kanamycin sulfate 1g, trimethoprim 0.2g, citric acid 0.2g, procaine hydrochloride 0.05g.
Preparation method:
Take respectively trimethoprim, the citric acid of recipe quantity, mix by fluid energy mill and pulverize, cross 120 mesh sieves, with tylosin tartrate, kanamycin sulfate, procaine hydrochloride, by the equivalent method of progressively increasing, mix homogeneously again, the inspection of semifinished product, packing, packing, product inspection, obtain.
Embodiment bis-
Tylosin tartrate 1g, kanamycin sulfate 1g, trimethoprim 0.2g, succinic acid 0.2g, procaine hydrochloride 0.05g.
Preparation method:
Take respectively trimethoprim, the succinic acid of recipe quantity, mix by fluid energy mill and pulverize, cross 120 mesh sieves, then mix homogeneously by the equivalent method of progressively increasing with tylosin tartrate, kanamycin sulfate, pain relief agents, the inspection of semifinished product, packing, packing, product inspection, warehouse-in, obtain.
Embodiment tri-
Tylosin tartrate 1g, kanamycin sulfate 1g, trimethoprim 0.2g, citric acid 0.2g, lidocaine hydrochloride 0.05g.
Preparation method:
Take respectively trimethoprim, the citric acid of recipe quantity, mix by fluid energy mill and pulverize, cross 150 mesh sieves, then mix homogeneously by the equivalent method of progressively increasing with tylosin tartrate, kanamycin sulfate, pain relief agents, the inspection of semifinished product, packing, packing, product inspection, warehouse-in, obtain.
Embodiment tetra-
Tylosin tartrate 1g, kanamycin sulfate 1g, trimethoprim 0.2g, succinic acid 0.2g, lidocaine hydrochloride 0.05g.
Preparation method:
Take respectively trimethoprim, the succinic acid of recipe quantity, mix by fluid energy mill and pulverize, cross 120 mesh sieves, then mix homogeneously by the equivalent method of progressively increasing with tylosin tartrate, kanamycin sulfate, pain relief agents, the inspection of semifinished product, packing, packing, product inspection, warehouse-in, obtain.
Embodiment five
Tylosin tartrate 0.5g, kanamycin sulfate 0.5g, trimethoprim 0.1g, citric acid 0.1g, procaine hydrochloride 0.05g.
Preparation method:
Take respectively trimethoprim, the citric acid of recipe quantity, mix by fluid energy mill and pulverize, cross 120 mesh sieves, then mix homogeneously by the equivalent method of progressively increasing with tylosin tartrate, kanamycin sulfate, pain relief agents, the inspection of semifinished product, packing, packing, product inspection, warehouse-in, obtain.
Embodiment six
Tylosin tartrate 0.5g, kanamycin sulfate 0.5g, trimethoprim 0.1g, succinic acid 0.1g, procaine hydrochloride 0.05g.
Preparation method:
Take respectively trimethoprim, the succinic acid of recipe quantity, mix by fluid energy mill and pulverize, sieve, then mix homogeneously by the equivalent method of progressively increasing with tylosin tartrate, kanamycin sulfate, pain relief agents, the inspection of semifinished product, packing, packing, product inspection, warehouse-in, obtain.
Embodiment seven
Tylosin tartrate 0.5g, kanamycin sulfate 0.5g, trimethoprim 0.1g, citric acid 0.1g, procaine hydrochloride 0.03g, lidocaine hydrochloride 0.02g.
Preparation method:
Take respectively trimethoprim, the cosolvent of recipe quantity, mix by fluid energy mill and pulverize, cross 120 mesh sieves, then mix homogeneously by the equivalent method of progressively increasing with tylosin tartrate, kanamycin sulfate, pain relief agents, the inspection of semifinished product, packing, packing, product inspection, warehouse-in, obtain.
Embodiment eight
Tylosin tartrate 0.5g, kanamycin sulfate 0.5g, trimethoprim 0.1g, citric acid 0.05g, succinic acid 0.05g, lidocaine hydrochloride 0.05g.
Preparation method:
Take respectively trimethoprim, the cosolvent of recipe quantity, mix by fluid energy mill and pulverize, sieve, then mix homogeneously by the equivalent method of progressively increasing with tylosin tartrate, kanamycin sulfate, pain relief agents, the inspection of semifinished product, packing, packing, product inspection, warehouse-in, obtain.
Result of study
1, prescription research
The present invention writes out a prescription with crude drug tylosin tartrate, kanamycin sulfate, trimethoprim, records one one of " Chinese veterinary pharmacopoeia " version in 2010." Chinese veterinary pharmacopoeia " record, similar to the erythromycin antimicrobial spectrum.A little less than effect to antibacterial, strong to the Mycoplasma effect, be one of medicine that the macrolide apoplexy due to endogenous wind is the strongest to the mycoplasma effect.Sensitive organism produces drug resistance to this product, and staphylococcus aureus has part crossing drug resistant phenomenon to this product and erythromycin; The antimicrobial spectrum of kanamycin sulfate is similar to streptomycin, but effect is slightly strong.Most of gram negative bacterias are had to powerful antibacterial action as escherichia coli, Bacillus proteus, Salmonella and pasteurella multocida etc., also more responsive to gold-coloured staphylococci and tubercule bacillus.Intramuscular injection is used for the various severe infections due to sensitive organism, as septicemia, urogenital infection, respiratory tract infection, Skin and soft tissue infection etc.; Trimethoprim is the broad-spectrum antiseptic synergist, can the antibacterial action of multiple antibiotics be increased substantially, and can reduce the appearance of drug resistance strain.
The present invention's prescription is by tylosin tartrate, kanamycin sulfate drug combination, through trimethoprim potentiation, clinical trial shows, in the effect and purposes basis of " Chinese veterinary pharmacopoeia " record, the pain produced in the time of solving the tylosin tartrate injection, control livestock and poultry respiratory and digestive tract disease effect are more remarkable, and reduce the generation of drug resistance.
2, stability study
Product stability research of the present invention, be " veterinary drug stability test technical specification (the trying) " way of promulgating according to the Ministry of Agriculture, adopts temperature, humidity accelerated test and acceleration by light test, and three batch samples are carried out to stability study.
2.1 temperature, humidity accelerated test
2.1.1 test material
Product of the present invention: injection use compound potentiation tylosin tartrate for animals
Batch number: 110701,110702,110703
Product requirement: commercially available back
2.1.2 experimental condition: adopt the medicine stability test case, temperature is adjusted to 40 ± 2 ℃, and relative humidity is controlled at 75 ± 5%.
2.1.3 observing time: product of the present invention is placed 6 months, and at duration of test, each month sampling secondary, detected product by stability high spot reviews project.
2.1.4 investigation project: character, content, the investigation project is determined according to " veterinary drug stability test technical specification (the trying) " way of promulgating for the Ministry of Agriculture.
2.1.5 test data
Name of product: injection use compound potentiation tylosin tartrate for animals, product batch number: 110701
Name of product: injection use compound potentiation tylosin tartrate for animals, product batch number: 110702
Name of product: injection use compound potentiation tylosin tartrate for animals, product batch number: 110703
2.2 acceleration by light test
2.2.1 test material
Product of the present invention: injection use compound potentiation tylosin tartrate for animals
Batch number: 110701,110702,110703
Product requirement: commercially available back
2.2.2 experimental condition: in test, with in the proof box of medicine strong illumination, illumination is 4500 native 500LX
2.2.3 observing time: get product of the present invention and pack in the water white transparency container, be positioned in the light durability proof box, place ten days under the condition of illumination 4500LX ± 500LX, sampling when walking in the 5th, ten days, detect by stability high spot reviews project.
2.2.4 investigation project: character, pH value, clarity, content, investigation project are determined according to " veterinary drug stability test technical specification (the trying) " way of promulgating for the Ministry of Agriculture.
2.2.5 test data
Name of product: injection use compound potentiation tylosin tartrate for animals, product batch number: 110701
Name of product: injection use compound potentiation tylosin tartrate for animals, product batch number: 110702
Name of product: injection use compound potentiation tylosin tartrate for animals, product batch number: 110703
2.3 result of study: product three batch samples of the present invention are investigated by temperature, humidity accelerated test and first accelerated test, it is all up to specification that result shows that product characteristics, pH value, clarity, content etc. detect within each investigation time, compares every detection index with the O month without significant degree.
3. the clinical trial of injection use compound potentiation tylosin tartrate for animals
Method: choose ill moving, be divided at random experimental group, matched group 1 and matched group 2:
(1) drug test group intramuscular injection injection use compound potentiation tylosin tartrate for animals of the present invention;
(2) medicine matched group 1 intramuscular injection injection tylosin tartrate matched group; Manufacturer: Chongqing gold nation animal pharmaceutical estate company limited, effective ingredient: tylosin tartrate, trimethoprim.
(3) medicine matched group 2 intramuscular injections kanamycin sulfate matched group; Manufacturer: the golden nation of gold celebrating animal pharmaceutical estate company limited, effective ingredient: kanamycin sulfate, trimethoprim.
Therapeutic dose: test group is in tylosin, 1kg body weight 5mg; Matched group 1 is in tylosin, 1kg body weight 10mg; Matched group 2 is in kanamycin sulfate, 1kg body weight 10mg.After treatment starts, with identical administering mode and corresponding disease, every day entry infected animal health situation of change, treat after 2 days and add up therapeutic outcome.
Result shows, matched group 1,2 comparisons of injection use compound potentiation tylosin tartrate for animals and folk prescription medicine, and the treatment disease effects obviously is better than matched group.The compound of the more existing tylosin tartrate of curative effect and trimethoprim or the compound of kanamycin sulfate and trimethoprim significantly strengthen.The disease of animal of take disappears fully as healing.
The clinical application effect statistics of injection use compound potentiation tylosin tartrate for animals
Claims (6)
1. the preparation method of an injection use compound potentiation tylosin tartrate for animals, is characterized in that, step comprises:
0.2 part of trimethoprim, 0.2 part of cosolvent, pulverize after mixing, and crosses 120 orders or thinner sieve;
With 0.05～0.1 part of 1 part of tylosin tartrate, 1 part of kanamycin sulfate, pain relief agents, by the equivalent method of progressively increasing, mix homogeneously again;
Inspection of semifinished product content, dissolubility, qualified rear packing, obtain.
2. the preparation method of a kind of injection use compound potentiation tylosin tartrate for animals according to claim 1, it is characterized in that: described pulverizing is for to pulverize through fluid energy mill.
3. the preparation method of a kind of injection use compound potentiation tylosin tartrate for animals according to claim 2, is characterized in that: described sieving as crossing 120 mesh sieves.
4. the preparation method of a kind of injection use compound potentiation tylosin tartrate for animals according to claim 3 is characterized in that: described cosolvent is citric acid or succinic acid or the two is composite.
5. the preparation method of a kind of injection use compound potentiation tylosin tartrate for animals according to claim 4 is characterized in that: described pain relief agents is procaine hydrochloride or lidocaine hydrochloride or the two is composite.
6. a kind of injection use compound potentiation tylosin tartrate for animals according to claim 1, is characterized in that: 0.05 part of described pain relief agents.
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| CN2013103647339A CN103432151A (en) | 2012-08-06 | 2012-08-06 | Preparation method for compound synergistic tylosin tartrate |
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| CN2013103647339A CN103432151A (en) | 2012-08-06 | 2012-08-06 | Preparation method for compound synergistic tylosin tartrate |
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| CN 201210277080 Division CN102784158B (en) | 2012-08-06 | 2012-08-06 | Preparation method of compound synergy tylosin tartrate for veterinary injection |
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| CN101468032A (en) * | 2007-12-26 | 2009-07-01 | 天津瑞普生物技术集团有限公司 | Soluble powder for treating respiratory illness of livestock and poultry |
| CN101822688A (en) * | 2010-05-19 | 2010-09-08 | 陈建波 | Compound tylosin injection for animals and preparation method thereof |
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2012
- 2012-08-06 CN CN2013103647339A patent/CN103432151A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1843329A (en) * | 2006-05-17 | 2006-10-11 | 天津生机集团有限公司 | Compound amikacin sulfate injection for animal and its preparation method |
| CN101468032A (en) * | 2007-12-26 | 2009-07-01 | 天津瑞普生物技术集团有限公司 | Soluble powder for treating respiratory illness of livestock and poultry |
| CN101822688A (en) * | 2010-05-19 | 2010-09-08 | 陈建波 | Compound tylosin injection for animals and preparation method thereof |
Non-Patent Citations (2)
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| 倪谷音: "兽医常用抗微生物药物的合理使用", 《动保药品》 * |
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